VAXZEVRIA Japan Post-Marketing Surveillance (PMS) for the Long-term Safety of VAXZEVRIA

VAXZEVRIA Intramuscular Injection General Use Result Study for the Long-term Safety of VAXZEVRIA

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05135455

Enrollment

467

Registered

2021-11-26

Start date

2022-04-21

Completion date

2023-08-31

Last updated

2024-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of Infectious Disease Caused by SARS-CoV-2

Brief summary

Detailed description

This survey will be conducted for the subjects who participate in the priority survey (cohort survey) conducted by the Scientific Research Group of the Ministry of Health, Labour and Welfare at the initial stage of administration of the COVID-19 vaccination. The present study aims to collect information on serious adverse events (including Thrombosis in combination with thrombocytopenia, Immune-mediated neurological conditions, Vaccine-associated enhanced disease (VAED) including Vaccine-associated enhanced respiratory disease(VAERD), Thrombosis or other diseases) or COVID-19 infection observed from 28 days after the last vaccination of VAXZEVRIA up to 12 months after the last vaccination and to evaluate the long-term safety of this vaccine.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

The subjects who participated in the cohort study conducted by the Scientific Research Group of the MHLW and those who give written consents for this study.

Exclusion criteria

None

Design outcomes

Primary

Measure	Time frame	Description
The incidence of SAEs will be calculated by preferred term (PT) by overall and with/without causal relationships with VAXZEVRIA assessed by investigator(s).	From the next day of 28 days after the last vaccination of VAXZEVRIA up to 12 months after the last vaccination.	The incidence of SAEs (including thrombosis in combination with thrombocytopenia, immune-mediated neurological conditions and VAED including VAERD, thrombosis or other diseases) will be calculated by preferred term (PT) by overall and with/without causal relationships with VAXZEVRIA assessed by investigator(s).
Number of the subjects considered to be severe case of COVID-19 and its incidence (%) will be calculated. The subject who required a hospitalization in intensive care unit or use of respirator will be defined as a severe case.	From the next day of 28 days after the last vaccination of VAXZEVRIA up to 12 months after the last vaccination.	Number of the subjects considered to be severe case of COVID-19 and its incidence (%) will be calculated. The subject who required a hospitalization in intensive care unit or use of respirator will be defined as a severe case based on the severity classification reference of A guide for front-line healthcare workers (MHLW, 2020). Ad hoc analysis might be performed as necessary.

Countries

Japan

Outcome results